Efficacy of Tadalafil (5mg) For Treatment of Early Storage Symptoms and Erectile Dysfunction After Endoscopic Enucleation of Prostate

NCT05955001 | Recruiting Phase 2

• 1 other identifier: MS.22.11.2208
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

From previous studies, the investigators found that sexual outcomes after prostate surgery may show insignificant improvement, remain unchanged or deteriorate in non-negligible number of patients especially those with high preoperative IIEF scores. Deterioration of erectile function could be attributed to persistence of storage symptoms specially nocturia. Several pathophysiologic mechanisms, described before, are involved in pathogenesis of LUTS and ED and one can imagine that after relief of obstruction, the erectile function should improve, however lack of improvement or even deterioration suggests that damage associated with these mechanisms is irreversible and patients may require some sort of penile rehabilitation after surgery. The investigators hypothesized that Tadalafil may enhance relief of storage symptoms and enhance recovery of erectile function after surgery for BPH. With this assumption, a RCT was designed to examine the utility and efficacy of Tadalafil, once daily dose, to relieve persistent/ de novo storage symptoms and early erectile function deterioration after endoscopic prostate surgery.

Conditions

Erectile Dysfunction; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Orgasm perception domain of International Index of Erectile Function (IIEF-15) questionnaire at 6 months among the study groups

  the erectile function will be assessed using a validated questionnaire and compared to baseline .

  1 and 3 months postoperatively (during treatment), and at 6 months postoperatively (3 months after treatment cessation)

Secondary Outcomes (1)

• Change in International Prostate Symptom Score (IPSS) with its subdomains voiding and storage once at different follow up points.

  2 weeks, 1, 3 months (during treatment) and at 6 months postoperatively ( 3 months after treatment cessation)

Study Arms (2)

Tadalafil 5 mg daily

EXPERIMENTAL

those patients will receive Tadalafil 5 mg daily after HoLEP

Drug: Tadalafil 5mg / Placebo

Placebo

EXPERIMENTAL

Those patients will receive Placebo after HoLEP

Drug: Tadalafil 5mg / Placebo

Interventions

Tadalafil 5mg / Placebo DRUG

Patients after Holmium laser Enucleation of Prostate (HoLEP) will receive single daily dose of Tadalafil for 3 months and compared to Placebo

Also known as: Placebo

Placebo; Tadalafil 5 mg daily

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients' age ≥ 40 years
• LUTS secondary to BOO due to BPH who failed medical treatment
• International prostate symptom scores (IPSS) \>15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
• Peak urinary flow rate (Qmax) \<15 ml/sec.
• ASA (American society of anaesthesiologists) score ≤ 3.
• Sexually active men, not receiving PDE5I

You may not qualify if:

• Patients using nitrates, potassium channel opener, or α1-blockers doxazosin and terazosin for control of hypertension
• Patients with unstable angina pectoris, recent myocardial infarction or stroke myocardial insufficiency.
• Patients with severe hepatic or renal insufficiency.
• Patients who are sexually inactive.
• Patients with uncontrolled diabetes mellitus or neurologic condition(eg. parkinsoism)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Lower Urinary Tract Symptoms

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Mahmoud Laymon, MD,MRCS

  Urology and nephrology center, Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Laymon, MD,MRCS

CONTACT

01002275698; dr_mahmoudlaymon@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 20, 2023
• Study Start: April 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

EG (1)